|Document(s)||Language||Status||First published||Last updated||Effective Date|
|Guideline on requirements for Plasma Master File (PMF) Certification||(English only)||adopted||2004-02-26||2004-03-31|
|Standard operating procedure for coordinating pre-approval inspections in the context of plasma-master-file certification||(English only)||adopted||2004-07-21||2013-04-30||2013-04-29|
- Variation guideline and PMF list* (see section D and B.V.a)
- European Medicines Agency Post-Authorisation Guidance (Ref. Variations type I)
- European Medicines Agency Post-Authorisation Guidance (Ref. Variations type II)
- Commission guideline on PMF 2nd step
- *Note: Transfer of PMF to a new Holder and 2nd step procedure since 01.01.2010 are handled as variation procedures.